Assist in the development of chromatography, electrophoresis, spectroscopy and mass spectrometry-based analytical methods to support product release, stability, and characterization testing for large molecule therapeutics.
Compensation
Salary Range: $106,000.00 to $138,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
Responsibilities
Assist in the development of chromatography, electrophoresis, spectroscopy and mass spectrometry-based analytical methods to be used for product release, stability, and characterization testing.
Contribute to the design and execution of experiments for demonstrating method robustness and performance.
Prioritize and perform timely testing that enables bioprocess and formulation development teams to meet project timelines.
Critically evaluate analytical data to support method development decisions and product quality comparisons.
Maintain accurate and timely experiment records in electronic laboratory notebook (ELN).
Requirements
B.S. or M.S. in Analytical Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences or related scientific discipline
Represent Product Development on CMC project teams across all stages of development from early discovery through commercial launch. Provide formulation and analytical expertise to support multiple preclinical and clinical programs.
Compensation
The annual base salary we reasonably expect to pay is $110,800.00-$151,000.00... In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program.
Responsibilities
Collaborate cross-functionally with Research/Discovery, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, Supply Chain, and external CDMO partners
Apply first principles of formulation and process science to design and execute preformulation and formulation development studies
Plan and execute studies using Quality by Design (QbD) principles, including Design of Experiments (DOE)
Prepare, evaluate, and optimize formulations for preclinical and clinical use
Lead pilot-scale and commercial process scale-up activities
Senior Process Chemist responsible for driving process optimization and innovation in active ingredient production within the Chemical Manufacturing team.
Responsibilities
Plan, prepare and carry out chemical experiments on new and existing active-ingredient processes, up to multi-kilo scale.
Support the adoption and effective use of laboratory automation, digital tools and structured data practices.
Generate and lead improvement projects from planning through implementation.
Communicate with cross-functional teams to exchange information and progress development work.
Maintain detailed documentation in lab notebooks and technical reports.
Support developmental activities to characterize gene therapy products through analytical methods and contribute to cross-functional activities for continuous improvement.
Compensation
Expected Annual Base Salary Range for role at Expert and Senior Expert levels: Expert (level 3) $93,800.00 - 134,000.00 - 174,200.00; Senior Expert (level 4) $119,700.00 - 171,000.00 - 222,300.00
Responsibilities
Contribute to all project/network strategy and drive the implementation; apply scientific/technical/ GMP and/or quality-related expertise to address complex R&D issues within a multifunctional project team.
Work with/coach team members and contribute to global technical strategies and goals; maintain and qualify equipment/infrastructure and manage operational aspects in lab as assigned.
Design, plan, perform, interpret and report scientific experiments or GMP testing or pilot plant processes for the preparation and timely delivery of drug substances (DS), drug products (DP), processes or procedures.
Design, plan, and perform product characterization studies using cell-based assays and other plate-based assays using variety of platforms including ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader
Identify, develop, validate and implement novel analytical assays and new GMP-compliant methodologies for pipeline gene therapy products.
Requirements
Biology
Biochemistry
Molecular Biology
Immunology
Expert/Senior* Expert Gene Therapy Analytical Development - Bioassay
Support developmental activities to aid in delivering gene therapy to patients, including analytical method development, validation, and characterization of gene therapy products.
Compensation
Expected Annual Base Salary Range for role at Expert and Senior Expert levels: Expert (level 3) $93,800.00 - 134,000.00 - 174,200.00 Senior Expert (level 4) $119,700.00 - 171,000.00 -222,300.00
Responsibilities
Contribute to all project/network strategy and drive implementation
Work with/coach team members and contribute to global technical strategies
Maintain and qualify equipment/infrastructure and manage operational aspects in lab
Design, plan, perform, interpret and report scientific experiments or GMP testing
Design, plan, and perform product characterization studies using cell-based assays and other plate-based assays
Requirements
Bachelor's degree in biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline
Lead integrated CMC program for early-stage biologics, providing strategic, technical, and operational direction across cross-functional teams to advance pipeline biologics from candidate selection through early clinical development and FIH milestones.
Compensation
The salary range for the primary location of this role is: $156,900.00 - $247,000.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Responsibilities
Lead and operationalize matrixed CMC project teams
Drive strategic and operational alignment across key CMC interfaces
Proactively identify program vulnerabilities and formulate contingency plans
Define and champion phase-appropriate analytical control strategies
Guide and contribute to technical authoring of regulatory filings
Requirements
Ph.D. in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, Biophysics, or related scientific discipline
A high-visibility role combining integrated cross-functional program leadership with deep subject-matter expertise (SME) in biologics analytical development, advancing pipeline biologics from candidate selection through early clinical development.
Compensation
$156,900 - $247,000
Responsibilities
Serve as the Early-Stage Development and Commercialization Team (DCT) Lead for assigned pipeline biologics, holding accountability for integrated CMC development strategy, milestone readiness, and cross-functional alignment.
Lead and operationalize matrixed CMC project teams; establish transparent team structures, functional working groups, clear decision rights, and milestone-driven timelines.
Drive strategic and operational alignment across key CMC interfaces, including Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, and external partners.
Proactively identify program vulnerabilities, evaluate cross-functional trade-offs, and formulate data-driven contingency plans.
Define and champion phase-appropriate analytical control strategies, product characterization workflows, and specification-setting rationales for early-phase biological modalities.
Senior Scientist role within the multiscale separations team responsible for chromatographic isolation of pharmaceutical API and impurities from analytical to prep and prep scale.
Compensation
The salary range for the primary location of this role is: $117,000.00 - $184,200.00
Responsibilities
chromatographic isolation of pharmaceutical API and impurities
partner with process chemists and analytical scientists to deploy efficient and fit-for-purpose chemical isolation methods
establish innovative purification workflows
deliver high purity materials
translate R&D problem solving into impactful pipeline deliveries
Principal Scientist, Early DCT LeadMerck · Rahway, US